Fluid delivery systems and methods and assemblies for making connections

ABSTRACT

A connector assembly includes first and second fittings including first and second membrane assemblies, respectively, and a stem member. A fluid delivery system includes a connector assembly, a container for holding fluids and tubing which couples the container to one of the first and second fittings. A method for making a contaminant-free connection comprises mating first and second fittings, and establishing a fluid flow path through the first and second fittings. The systems, assemblies and methods according to the invention may be used, for example, to handle a biological fluid while maintaining the fluid free of viable contaminating microorganisms or preserving its sterility.

This application is a continuation-in-part application of PCTApplication No. PCT/US93/09450 filed Oct. 1, 1993 which is acontinuation-in-part of U.S. patent application Ser. No. 07/956,854filed Oct. 2, 1992.

FIELD OF THE INVENTION

The present invention relates to fluid delivery systems and methods andassemblies for making connections. More particularly, the inventionrelates to fluid delivery systems and methods and assemblies for makingconnections assembly which maintain the sterility of a fluid, forexample, a biological fluid, which passes through the connectorassembly.

BACKGROUND OF THE INVENTION

Connector assemblies have been developed to handle fluids, e.g.,biological fluids, while preserving their condition. More particularly,connectors have been developed to preserve the condition of a fluid, ormaintain a fluid free of contaminants. Freedom from contaminants refersto a relative amount of contaminants and is variously defined accordingto a specific industry, fluid and/or intended use. For example, abiological fluid which is substantially free of contaminants isconsidered free of viable micro-organisms, and is typically referred toas "sterile". Connector assemblies for use with biological fluids, forexample, have been fashioned to preserve sterility of the fluid.

Attempts have been made to develop connector assemblies which isolate afluid from the ambient environment of the connector, and fromcontaminants entrained in the ambient. Such connectors typically definea fluid conduit which is isolated from the ambient. Some conventionalconnector assemblies include mating male and female connectors havingopposing, exposed surfaces. One surface may comprise the surface of amembrane, for example, while the other surface may comprise the surfaceof a rubber septum forming a blind end of an elastic, collapsible tube.These surfaces may be wiped with an antiseptic, then resiliently urgedin contact when the connectors are coupled. Other conventional connectorassemblies provide a removable protective cover on each opposing surfaceto be contacted. These covers must be removed prior to actually couplingthe connectors.

Many problems are associated with these conventional connectorassemblies. For example, wiping the surfaces with an antiseptic orremoving the covers of these conventional connector assemblies may notsufficiently protect the fluid flowing through these assemblies. Thesurfaces are wiped and the covers are removed usually by hand. Althoughthe attendant may use surgical gloves, a gloved finger may trail theantiseptic wipe along the protected surface, depositing on the surfacecontaminants that were on the glove. To unfasten and remove a cover, thegloved hand must manipulate the removable cover in intimate proximity tothe protected surface under the cover, again risking incidental contactand the transmission of contaminants between the glove and the protectedsurface.

In addition, once the surfaces are wiped with an antiseptic or theprotective covers are removed from the protected surfaces, the surfacesare exposed to the contaminant-laden ambient environment. For example,as the connectors are brought together, dust, micro-organisms, and otherairborne contaminants may contact the protected surfaces, even if theconnectors are quickly mated. Thus, while these conventional connectorassemblies have been developed to form a sterile connection, noneadequately protect the fluid flowing through the connector assembly.

SUMMARY OF THE INVENTION

In accordance with a first aspect, the present invention is directed toa connector assembly comprising a first fitting defining a firstaperture, a second fitting coupled to the first fitting and defining asecond aperture, a stem member mounted in the first fitting andincluding a head, and a ratchet mechanism. The ratchet mechanismincludes first and second ratchet structures spaced apart from oneanother and a section between the first and second ratchet structureshaving a lower resistance to movement of the stem member than the firstand second ratchet structures. The stem member being axially movableinto the aperture of the second fitting. The ratchet mechanism ismounted to the stem and operates to lock the head of the stem within thesecond aperture of the second fitting. The ratchet mechanism includesfirst and second ratchet structures spaced apart from one another and asection between the first and second ratchet structures having a lowerresistance to the movement of the stem member than the first and secondratchet structures.

In accordance with a second aspect, the present invention is directed toa method for making a contaminant-free connection. The method comprisesmating a first fitting and a second fitting, establishing a fluid flowpath through the first and second fittings by advancing a stem having ahead from the first fitting into the second fitting, and locking thehead of the stem in the aperture of the second fitting. Advancing thestem includes moving the stem against a first resistance, a secondresistance substantially less than the first resistance, and a thirdresistance substantially greater than the second resistance.

In accordance with a third aspect, the present invention is directed toa fluid delivery system comprising a connector assembly. The connectorassembly includes a first fitting defining a first aperture, a secondfitting coupled to the first fitting and defining a second aperture, andstem member mounted in the first fitting and including a head. The firstfitting includes a first removable contamination containment layersealing the first aperture, and the second fitting includes a secondremovable contamination containment layer sealing the second aperture.The stem member being axially movable into the aperture of the secondfitting.

In accordance with a fourth aspect, the present invention is directed toa fluid delivery system comprising a connector assembly a container forholding fluids and tubing which couples the container to one of thefirst and second fittings. The connector assembly includes a firstfitting defining a first aperture, a second fitting defining a secondaperture, and a resilient mount positioned between the first and secondfittings and communicating with the first and second apertures. Thefirst fitting includes a first removable contamination containment layersealing the first aperture, and the second fitting includes a secondremovable contamination containment layer sealing the second aperture.The resilient mount including a hub and a neck joined to the hub systemcomprises a connector assembly, a container for holding fluids andtubing. The connector assembly includes a first fitting defining a firstaperture, a second fitting couplable to the first fitting and defining asecond aperture, and a stem member. The stem is mounted in the firstfitting and includes a head axially movable into the aperture of thesecond fitting. The tubing couples the container to one of the first andsecond fittings, and is connected directly to the container and to oneof the first and second fittings.

The methods and systems and assemblies according to the invention mayprovide a contaminant-free fluid flow path by providing a membraneassembly having a contaminant containment layer or surface which can beremoved to expose an underlying contaminant-free membrane or layer. In apreferred embodiment of the invention, structural elements of thefittings urge the membrane assemblies together, whereby access bycontaminants is significantly reduced or eliminated.

Embodiments of the present invention may be used preferably with asterile fluid, such as a biological fluid. A sterile fluid is one whichis substantially free of viable contaminating microorganisms. Connectorassemblies and fluid delivery systems according to the invention definea fluid communication path wherein the fluid is maintained free ofviable contaminating microorganisms, or the sterility of the fluid isnot adversely affected by the passage of the fluid through the assemblyor the system.

The novel features and characteristics of this invention are set forthwith particularity in the appended claims. However, the invention maybest be understood with reference to the drawings, described below, andthe accompanying detailed description of preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevation view, in partial section, of disassembledcomponents of a connector assembly in one embodiment according to theinvention.

FIG. 2 is plan view of a female connector in the embodiment of FIG. 1.

FIG. 3 is plan view of a male connector in the embodiment of FIG. 1.

FIG. 4 is an elevation in cross section of a resilient mount in theembodiment of FIG. 1.

FIG. 5a is a schematic of one embodiment of a membrane assemblyaccording to the invention.

FIG. 5b is a schematic of another embodiment of a membrane assemblyaccording to the invention.

FIG. 6 is an elevation view in partial section of the components of FIG.1 in partial assembly.

FIG. 7 is an elevation view in partial section, of the components ofFIG. 1 in final assembly.

FIG. 8 is an elevation view in partial section of a male connector inanother embodiment of a connector assembly according to the invention.

FIG. 9 is an elevation view in partial section of the male connector ofFIG. 8, in final assembly.

FIG. 10 is an elevation view in section of another embodiment of afemale connector in a connector assembly according to the invention.

FIG. 11 is an elevation view in partial section of the components of analternative embodiment of the invention in partial assembly.

FIG. 12 is an elevation view in partial section of the components of analternative embodiment of the invention in final assembly.

FIG. 13 is a plan view of a portion of the male connector in theembodiment of FIG. 11.

FIG. 14 is an elevation view, in partial section, of disassembledcomponents of a connector assembly--fluid delivery system combinationaccording to the invention.

FIG. 15 is an elevation view, in partial section, of disassembledcomponents of a connector assembly--fluid delivery system combination inan alternate embodiment according to the invention.

FIG. 16 is an elevation view, in partial section, of disassembledcomponents of a connector assembly--fluid delivery system combination inan alternate embodiment according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

A connector assembly according to the present invention includes matingconnectors or fittings which can be coupled to connect different fluidconduit sections, defining a fluid flow path, e.g., a liquid flow path.The connector assembly isolates the fluid flow path from the ambientenvironment and from contaminants present in the ambient environment andis preferably sterile. Consequently, a connector assembly according tothe present invention is suitable for use in an open system, a closedsystem, or a closed sterile system.

In a preferred embodiment illustrated in FIGS. 1-3, the connectorassembly comprises two connectors, preferably a female connector 100 anda male connector 200. Each connector may be attached to any suitablefluid conduit section, for example, an inlet or outlet of a housing suchas a blood filter. In the illustrated embodiment, the fluid conduitscomprise sections of tubing 10, 20. Each connector may comprise anystructure suitable to conduct fluid communication, preferable liquidcommunication, e.g. a housing of any form capable of containing fluid.The exemplary female connector 100, typically of unitary construction,generally comprises a fitting 130 and a membrane assembly 170. Theexemplary male connector 200, typically of unitary construction,generally comprises a stem 210, a fitting 230 and a membrane assembly270.

In the disassembled view of FIG. 1, the connectors are disposedgenerally opposing each other. For directional orientation in thefollowing discussion, each connector has a proximate end, nearest theopposing connector, and a distal end, furthest from the opposingconnector. Also, since the exemplary connectors 100, 200 in FIG. 1comprise generally elongated bodies, the term axial denotes dispositionalong their axes.

The female and male connectors may comprise a detect mechanism adaptedto interlock the female connector in predetermined relation with themale connector. Thus, the female fitting 130 may include a bracket 148.The bracket 148 may be variously configured. The bracket 148 maycomprise a socket or cup having any suitable plan form, e.g. rectangularor circular. In the illustrated embodiment, the bracket 148 comprises aU-shaped bracket or clevis. The representative bracket 148 is defined bya flange 150 and side walls 156. The flange 150 may assume a radiallyextending annular plan form, for example, as best seen in FIG. 2.

The side walls 156 depend away from the flange 150 and toward theopposing male connector 200. One or more tongues 158 may depend from thewalls 156. The tongues 158 can be formed integrally with the walls 156,for example, by continuing middle sections of the walls 156. The tongues158 can thus register in grooves 248 formed in a flange 246 of the maleconnector 200, best seen in FIG. 6. Accordingly, tongues 158 can beadapted to couple the female and male connectors 100, 200 in atongue-in-groove engagement, as seen in the elevation view of FIG. 6 (inpartial assembly). Tapers 162 can be formed at the proximate ends of thetongues 158 to guide the insertion of the tongues 158 into the grooves248. Catches 160 can be formed which pass through the grooves 248,abutting a distal surface of the flange 246 and antagonistically lockingthe female and male connectors 100, 200, as will be detailed below.

A socket 164, adapted to receive the male connector 200, is defined bythe space enclosed by the flange 150 and side walls 156. The proximatesurface of the flange 150 (i.e. the flange surface closest the opposingmale connector) provides a socket seat 152. The seat 152 serves as anabutment to the male connector 200 when the latter is positively engagedwith the female connector 100.

The female fitting 130 may define an internal chamber or aperture 141which may have any suitable configuration. The illustrated chamber 141may comprise a bore 142 relieved at its proximate end into a counterbore144. The flange seat 152 surrounds the counterbore 144. The illustrativefemale fitting 130 may be connected integrally with the section oftubing 10. The internal chamber 141 may be connected in fluidcommunication with the tubing 10.

In an important aspect of the invention, the female connector is adaptedto contain or provide fluid communication and preferably defines anisolated portion of the fluid path, e.g., containing or conductingisolated fluid communication. Accordingly, the chamber 141 is enclosedby a membrane assembly 170. The assembly of the female and maleconnectors 100, 200 may be surrounded by an atmosphere or ambientenvironment having contaminants. In one key function, the membraneassembly 170 isolates the chamber 141, and fluid therein, from thesurrounding ambient environment and from contaminants present in theambient environment. Regardless of when or how the connector 100 issterilized, the seal provided by the membrane assembly 170 is preferablysecure enough to maintain the sterility within the chamber 141 of femaleconnector 100. In the illustrated embodiment, the female connector 100is formed such that the fitting 130, the flange 150, the membraneassembly 170 comprise integral portions of the female connector 100.

The membrane assembly is preferably secured to the seat 152 of thefemale connector 100. Alternatively, the membrane assembly may bepositioned in any other suitable location, such as within the internalchamber and sealed to the walls of the bore or the counterbore. Themembrane assembly 170 can be secured to the seat 152 or the walls of thechamber 141 by a variety of means. Preferably, the membrane assembly 170can be secured by ultrasonic welding. Alternatively, the membraneassembly 170 may be secured by a heat seal or bonded by an adhesive or asolvent, preferably along the periphery.

FIGS. 1, 6, and 7 show elevation views of the male connector 200 indifferent stages of assembly with the female connector 100. FIGS. 1, 6,and 7 comprise views in partial section, as the stem 210 is shown inplain (i.e. non-sectioned) elevation. The male connector 200 generallyincludes a stem 210 housed in a fitting 230. The male connector 200 mayalso include a resilient mount 249 having a membrane assembly 270secured thereto.

The male connector 200 is preferably adapted to contain and conductfluid communication and preferably defines an isolated portion of thefluid flow path, e.g., containing or conducting isolated fluidcommunication. Accordingly, the stem 210 is preferably housed within asealed chamber or aperture 231 defined within the fitting 230. In theillustrative embodiment, the stem 210 is hollow, defining a lumen (notshown) therein. The proximate end of the stem 210 may have a head 220formed thereon. The head 220 may comprise a piercing element since itmay have a sharpened tip. The head 220 may have an aperture providingfluid access between the lumen and the exterior of the stem 210. Thestem 210 may also be connected to a fluid conduit section, e.g., thetubing section 20. If the stem 210 and tubing 20 are fabricated asseparate components, the tubing 20 may be joined to the base 223 usingsolvent, bonding or ultrasonic welding for example. Alternatively, thestem 210 and tubing 20 (or other fluid conduit structure) may be moldedas an integral part. The stem 210 may also be formed with a ratchetstructure, for example beveled annular ribs 216 formed on the externalsurface of the stem 210. These ribs 216 are shown in plain,non-sectioned elevation in the partially cross sectioned FIGS. 1, 6 and7. The ribs 216 may circumfuse the external surface of the stem 210. Theribs 216 may be beveled such that they project from the surface of thestem 210, extending distally toward the base 223 of the stem 210 andforming an acute angle with the external surface of the stem 210.

Although the male connector may be variously configured, the illustratedmale connector 200 comprises an arrangement of telescoping elementsadapted to house at least a portion of the stem 210 within the internalchamber 231 in isolation from contaminants. Thus, by way ofillustration, the fitting 230 may have a generally cylindrical sleeve232 extending from the flange 246. The sleeve 232 defines a bore 234forming a portion of the internal chamber 231. The stem 210 may registerintimately with the sleeve 232. In the illustrated embodiment, a headportion 220 of the stem 210 is housed within the sleeve 232.

The illustrative male fitting 230 may further be constructed with asecond outside sleeve 238 concentrically disposed about the first sleeve232. The concentric sleeves 232, 238 may be connected by any appropriatemeans. In the representative embodiment, the fitting 230 is formed suchthat the sleeves 232, 238 and the flange 246 comprise integral portionsof the fitting 230. Preferably, the outside sleeve 238 isolates both thestem 210 and the interior bore 234 of the inside sleeve 232 fromexposure to the ambient environment. Thus, the axial length of theinside sleeve 232 may be shorter than the axial length of the outsidesleeve 238. The remainder of the body of the stem 210 may be housedwithin an interior bore 239 defined within the outside sleeve 238.

The stem 210 may include a telescoping seal assembly adapted to mate intelescoping engagement with one or both of the sleeves 232, 238 toisolate and preferably seal the internal chamber 231. Generally, thetelescoping seal assembly may be adapted to engage either sleeve,internally or externally. In the exemplary embodiment, the seal assembly225 may mate in telescoping engagement at least with the interior bore239 defined in the outside sleeve 238. The telescoping assembly mayinclude elastomeric or deformable elements which intimately engage thewalls of the interior bore 239. As shown in the representativeembodiment of FIGS. 1, 6, and 7, the illustrative telescoping assembly225 may include a plunger 226 and an O-ring 227 which fits within agroove in the plunger 226. Preferably the plunger 226 and/or the O-ring227 tightly engage the inside wall of the outside sleeve 238. Thisengagement advantageously isolates the interiors of both the inside andoutside sleeves 232, 238 from the ambient.

The telescoping seal assembly may also mate with the inside sleeve 232to seal the internal chamber 231. For this purpose, the distal end ofthe sleeve 232 may be formed with a rim 233. The rim 233 may assume atapered form as shown. The telescoping seal assembly 225 mayadditionally include a shoulder 224 formed on a base 223 of the stem210. The shoulder 224 may have a tapered form adapted to mate with thatof the rim 233, providing another seal for the chamber 231.

Although the illustrated embodiment comprises an arrangement oftelescoping elements, the male connector may include other arrangementsfor advancing the stem. For example, a screw mechanism with a ratchetmay be mounted between the outer sleeve and stem. The stem could then beadvanced by rotating the screw mechanism.

As exemplified in the plan view of the male connector 200 in FIG. 3, theflange 246 may be generally annular, circumfusing and extending radiallyfrom the sleeve 232. The flange 246 may be formed with the grooves 248.As mentioned above, the engagement of one or more tongues 158 of thefemale connector 100 in the grooves 248 of the male connector 200 ispart of one possible structure for coupling the connectors 100, 200.This coupling is shown in an initial stage of engagement in FIG. 6.

In an important aspect of the invention, the female and male connectorsmay form a resilient coupling mechanism for engaging these connectors inbiased opposition. Though this resilient coupling mechanism may befashioned in a variety of ways, in the exemplary embodiment, thiscoupling mechanism may include the resilient mount 249. A representativeconstruction for the resilient mount 249 is detailed in the sectionedelevation view of FIG. 4. The mount 249 serves as a seat which has atleast one of the membrane assemblies secured thereon and which is atleast axially resilient (e.g. at least resilient along an axis of thesleeve 232). The resilient mount 249 may be disposed generally betweenthe female and the male connectors 100, 200, providing antagonismbetween the coupled connectors. The resilient mount 249 could beconnected to the female connector 100. However, in the illustratedembodiment the resilient mount 249 is connected to the male connector200.

As best shown in FIG. 4, the mount 249 may include a resilient neck 252connecting a hub 250 to the flange 246. The exemplary hub 250 defines asealable seat surrounding an opening into the chamber 231. Thus, the hub250 may have a wall 256 defining a well 262. The wall 256 may have anannular plan form, for example, as best shown in FIG. 3. The well 262communicates with the bore 234 in the sleeve 232. Together, theillustrative bore 234 and well 262 form the internal chamber 231. Thewall 256 may further have a rim 258. This rim 258 forms the sealableseat circumfusing the well 262 which accesses the chamber 231. Themembrane assembly 270 is preferably secured to the rim 258, enclosingthe internal chamber 231.

As detailed particularly in FIG. 4, the neck 252 may be formed with ajoint having a recess or groove, shown generally at 260. The groovedjoint 260 connects the neck 252 to the hub 250, on the distal side ofthe hub. When the connectors 100, 200 are engaged, the grooved joint 260yields, and the neck 252 is compressed at least axially. Thus, the axialresilience of the mount 249 urges the connectors into biased opposition,maintaining the membrane assemblies 170, 270 in positive contact. As onealternative to the grooved joint 260, the hub may be formed with a thinflange joining the neck.

The resilient mount 249 may be formed as an integral part of the malefitting 230. Thus, the sleeve 232, flange 246, neck 252 and/or hub 250may be molded integrally for example. In this embodiment, the malefitting 230, like the female fitting 130, is molded as a single partfrom any suitable polymeric material, for example olefinic compositionssuch as polypropylene, polyethylene, butadiene; acrylics;polycarbonates; or elastomers.

In the illustrated embodiment, the male connector 200 is formed suchthat the fitting 230, the resilient mount 249, and membrane assembly 270comprise integral portions of the male connector 200.

Preferably, the female and male connectors 100, 200 are interlocked inpredetermined relation and are resiliently coupled in antagonisticbiased opposition. The coupling structure on each connector may beproportioned relative to the other to produce an antagonistic coupling.As noted above, FIG. 6 shows the tongue-in-groove coupling of therepresentative female and male fittings 130, 230 in partial assembly.The catches 160 abut the distal surface of the flange 246, interlockingthe connectors 100, 200 in predetermined relation to each other. Thedimensions of the fittings 130, 230 are preferably proportioned suchthat when the catches 160 embrace the distal surface of the flange 246,the resilient mount 249, including the hub 250 and neck 252, compressesaxially, forces the membrane assemblies 170, 270 into positive contact,and provides biased opposition between the membrane assemblies 170, 270.To protect the resilient mount 249, shoulders 154a-154d, seenparticularly in FIGS. 1 and 2, may be formed preferably on the flange148 of the female connector 100. These shoulders may serve as stopslimiting the compression of the mount 249 by ensuring a minimum spacingbetween the connectors. Alternatively, the mount 249 may be constructedsuch that it can tolerate compression that is limited by contact betweenthe flanges 148, 246 and the hub 250.

Prior to coupling the connectors 100, 200, the proximate, opposingsurfaces of the membrane assemblies 170, 270, are exposed to the ambientenvironment. Upon coupling, these opposing surfaces are forced intopositive contact with each other due to the biased opposition imposed bythe resilient mount 249. In a principal feature of the invention, thispositive contact is maintained as long as the connectors 100, 200 arecoupled. Through this positive contact, the contacting surfaces of themembrane assemblies 170, 270 cover each other, isolating them from theambient.

The membrane assemblies of the connectors may be variously configuredand may be identical or not. FIGS. 5a and 5b are schematics showingdifferent embodiments for the membrane assemblies. In a principal aspectof the invention, each membrane assembly includes at least two layers orsurfaces. The first comprises a removable contamination containmentsurface. Initially, this surface comprises the proximate surface of eachrespective membrane assembly, i.e., the surface nearest and facing theopposing connector. The second surface of each membrane assemblycomprises a protected sealing surface. This surface is protected andpreferably isolated from the ambient environment and from contaminantspresent in the ambient environment. At least initially, prior to thestage of inserting the stem into the female connector, the sealingsurface seals the chamber defined within each respective fitting. InFIGS. 5a and 5b, in the membrane assembly 170 of the female connector100, the sealing surface and the contamination containment surface aredenoted by 174 and 182, respectively. In the membrane assembly 270 ofthe male connector 200, the sealing surface and the contaminationcontainment surface are denoted 274 and 282, respectively.

The layers or surfaces of the membrane assemblies may be variouslyconfigured. In the exemplary embodiment of FIG. 5a, the contaminationcontainment surface comprises a surface of a cover layer which may becompletely removed from the membrane assembly. This exposes a separateunderlying sealing layer, having the sealing surface as one of itssurfaces. In the embodiment of FIG. 5b, the contamination containmentsurface comprises a portion of a surface of a cover layer which isfolded in a serpentine configuration. This cover layer may be unfolded,exposing a protected cover layer portion, or may be removed completely,exposing a separate sealing layer.

FIG. 5a shows one preferred embodiment of the membrane assemblies 170a,270a. Each membrane assembly 170a, 270a, in the illustrative embodiment,comprises two separate layers. The membrane assembly 170a has a coverlayer 178a serving as a removable protective sheath covering a separatesealing layer 172a. The sealing surface 174a comprises the surface ofthe sealing layer 172a facing the female flange 148. The contaminationcontainment surface 182a comprises the surface of the cover layer 178afacing the male connector 200.

More particularly, the sealing layer 172a may enclose the chamber 141defined within the female fitting 130, preferably sealing it. Thus, thesealing surface 174a may be secured to the seat 152, preferablypermanently, using any of the techniques discussed above, e.g.ultrasonic welding. In this embodiment the sealing layer 172a is laidflat over the opening to the chamber 141 and because the sealing layer172a has no folds, it has only two surfaces, the sealing surface 174aand an intermediate surface 176a. Also preferably, the sealing layer172a may comprise a material which precludes the passage of bacteriatherethrough. This material my be porous, preferably having a porerating of about 0.2 μm or less. Alternatively, the sealing layer 172amay comprise a material which is impervious to both liquid and gas.Accordingly, in one key function the membrane assembly 170a isolates aportion of the fluid path from the ambient environment and fromcontaminants in the ambient environment since the sealing layer 172aseals the chamber 141.

In the illustrated embodiment, the cover layer 178a is disposed over thesealing layer 172a in a single fold configuration. The exemplary coverlayer 178a has a pull tab 179a (shown also in FIG. 2), an intermediatesurface 180a and the contamination containment surface 182a. When thecover layer 178a is attached to the sealing layer 172a, the intermediatesurface 176a of the sealing layer 172a and the intermediate surface 180aof the cover layer 178a are interfaced in intimate contact. The coverlayer 178a is preferably removably attached to the sealing layer 172a inany suitable manner. The sealing layer 172a and the cover layer 178a canbe attached together by heat sealing the perimeter of the intermediatesurfaces 176a, 180a, for example. Alternatively, the intermediatesurface 180a, but not the contamination containment surface 182a, of thecover layer 178a has a tackiness or an adhesive which releasably holdsthe cover layer 178a to the sealing layer 172a but which entirelyremains with the cover layer 178a when the cover layer 178a is removedfrom the sealing layer 172a. The contamination containment surface 182aof the cover layer 178a and the intermediate surface 176a of the sealinglayer 172a thus remain free of adhesive, preventing ambient contaminantsfrom being attracted to and held by either surface. Further, because theintermediate surface 176a of the sealing layer 172a remains free ofadhesive, there is no risk that the adhesive will leach into fluidflowing through the connector assembly.

Prior to coupling the female and male connectors 100, 200, thecontamination containment surface 182a is exposed to the ambientenvironment. Preferably, the cover layer 178a also comprises a material,such as glassine paper, which precludes the passage of bacteriatherethrough. Accordingly, while the cover layer 178a is attached to thesealing layer 172a, it isolates the sealing layer from the ambientenvironment. In another key function of the membrane assembly 170a, thecover layer 178a protects the sealing layer 172a, isolating it fromcontact with other surfaces, or surface area portions, or the ambientenvironment. More particularly, the cover layer 178a may beadvantageously folded as shown so that the intermediate surface 180aintimately interfaces with the sealing layer 172a and protects thesealing layer 172a from even the exposed contamination containmentsurface 182a.

The membrane assembly 270a of the male connector 200 has a constructionanalogous to that of the membrane assembly 170a. The membrane assembly270a has a sealing layer 272a and a cover layer 278a. The sealingsurface 274a comprises the surface of the sealing layer 272a facing themale flange 246. The contamination containment surface 282a comprisesthe surface of the cover layer 278a facing the female connector 100.

The sealing layer 272a seals the well 262, and thus the chamber 231defined within the male fitting 230. Accordingly, the sealing surface274a is secured to the rim 258 of the axially resilient hub 250. Thesealing surface 274a may be secured, preferably permanently, using anyof the techniques outlined above, e.g. ultrasonic welding. The sealinglayer 272a may be laid flat over the well 262. Because the sealing layer272a has no folds in this embodiment, it has two surfaces, the sealingsurface 274a and an intermediate surface 276a. The sealing layer 272amay be impervious to gas or liquid or may comprise a porous, hydrophobicmaterial which precludes the passage of bacteria therethrough. Thesealing layer 272a thus isolates the chamber 231 from the ambient andfrom contaminants entrained in the ambient.

As in the female connector, the cover layer 278a may similarly beremovably attached to the sealing layer 272a. This cover layer 278a mayalso be disposed over the sealing layer 272a in a single foldconfiguration. The exemplary cover layer 278a has a pull tab 279a (shownalso in FIG. 2), an intermediate surface 280a and the contaminationcontainment surface 282a. When the cover layer 278a is attached to thesealing layer 272a, the intermediate surface 276a of the sealing layer272a and the intermediate surface 280a of the cover layer 278a areinterfaced in intimate contact. Accordingly, while the cover layer 278ais attached to the sealing layer 272a, it isolates the sealing layerfrom the ambient and from contact with other surfaces exposed to theambient.

In each of the previous embodiments of the membrane assemblies 170, 270,the cover layer 178, 278 intimately contacts the sealing layer 172, 272.However, the membrane assembly may alternatively be configured with thesealing layer spaced from the cover layer. For example, the cover layermay be removably attached to the flange of the connector, enclosing thechamber, while the sealing layer is spaced from the cover layer andpositioned within the chamber sealed to the walls of the bore.

The antagonistic coupling of the connectors created by thetongue-in-groove engagement and the axially resilient mount 249 urgesthe respective contamination containment surfaces 182a, 282a, intobiased opposition. This resilience ensures positive contact between thecontamination containment surfaces 182a, 282a as long as the connectors100, 200 are coupled.

Preferably, the fittings 130, 230, and thus the surfaces within thefittings defining the chambers 141, 231, may be sterilized either beforeor upon assembly with each other. Each of the sealing surfaces 174a,274a seals its respective chamber 141, 231, isolating the chamber fromthe ambient and contaminants entrained therein.

According to a principle aspect of the invention, each of thecontamination containment surfaces 182a, 282a can be removed whilemaintaining these surfaces in positive contact. Once the connectors 100,200 are coupled, they form a housing and the pull tabs 179a, 279a of thecover layers 178a, 278a preferably abut each other and extend in thesame direction to the exterior of the housing. For example, in theembodiment illustrated in FIG. 6, the pull tabs 179a, 279a extend out ofthe channel of the U-shaped bracket 148 (i.e., into or out of the planeof the drawing page), beyond the assembly of the two connectors 100,200. The pull tabs 179a, 279a can be pulled by hand, pinching the tabstogether with two fingers. The tabs 179a, 279a are most preferablypulled simultaneously, while maintaining the contamination containmentsurfaces 182a, 282a in biased contact. When the tabs are pulledtogether, the biased opposition of the resilient coupling maintains thepositive contact between the contamination containment surfaces 182a,282a. Each contamination containment surface 182a, 282a may trap andisolate any contaminants on the other. Even as the cover layers 178a,278a are removed, the resilient mount 249 urges the contaminationcontainment surfaces 182a, 282a into positive contact with each other.Also, a bacteriostatic or bacteriocidal compound or layer could bedisposed on either or both contamination containment surfaces 182a,282a. As the cover layers 178a, 278a are removed, each contaminationcontainment surface 182a, 282a is pulled away from the respectivesealing layer 172a, 272a by virtue of the advantageous foldconfiguration. Thus, in another key feature the membrane assemblies170a, 270a isolate both the fluid path and surfaces intersecting thefluid path, e.g., the intermediate surfaces 176a 276a at the sealinglayers 172a, 277a, from the ambient and surfaces exposed to the ambient,e.g., contamination containment surfaces 182a, 282a.

In addition to being axially resilient, the resilient mount 249 ispreferably flexible enough to tilt laterally or rock as the cover layers178a, 278a are removed. Thus, as the cover layers 178a, 278a areremoved, the hub 250 instantly urges the protected intermediate surfaces176a, 276a of the sealing layers 172a, 272a into positive contact,virtually preventing contamination of these surfaces.

Each contamination containment surface 182a, 282a isolates the other,trapping therebetween any contaminants incident on the surfaces from theexposure of these surfaces to the ambient. The membrane assemblies 170a,270a isolate both internal chambers 141, 231, and the fluid path portiondefined within the stem 210, from the ambient. Further, the membraneassemblies 170a, 270a isolate both internal chambers 141, 231, and thefluid path portion defined within the stem 210, from surfaces exposed tothe ambient, e.g., from the contamination containment surfaces 182a,282a. When the two connectors 100, 200 are coupled and the cover layers178a, 278a are removed, only surfaces which were previously isolateddefine or intersect the fluid flow path.

In the embodiment of FIG. 5b, each membrane assembly 170b, 270bcomprises at least one sheet arranged in a serpentine foldconfiguration. Each fold defines a portion of the sheet forming a newlayer. Thus, the membrane assembly 170b can comprise a single sheethaving one portion forming the sealing layer 172b. Another portion ofthe sheet after the first fold in the serpentine configuration forms afirst cover layer 178b. Yet another portion of the sheet after thesecond fold in the serpentine configuration forms a second cover layer181b.

More particularly, the sheet portion forming the sealing layer 172b hastwo surfaces, a sealing surface 174b and an intermediate surface 176b.Analogous to the embodiment of FIG. 5a, the sealing surface 174b may besecured to the seat 152 of the female fitting 130, preferablypermanently. Preferably, the sealing layer 172b comprises a materialwhich precludes the passage of bacteria. Thus the membrane assembly 170bisolates a portion of the fluid path from the ambient and contaminantspresent in the ambient since the sealing layer 172b seals the chamber141.

The first cover layer 178b may be removably attached to the sealinglayer 172b as previously discussed with respect to the embodiment shownin FIG. 5a. The first cover layer 178b has an intermediate surface 180b.When the membrane assembly 170b is folded, the intermediate surface 176bof the sealing layer 172b and the intermediate surface 180a of the firstcover layer 178b are interfaced in intimate contact.

The second cover layer 181b may be disposed over the first cover layer178b. The second cover layer 181b has a pull tab 179b and acontamination containment surface 182b. The contamination containmentsurface 182b comprises the surface of the membrane assembly 170b mostproximate to the opposing male connector 200. Prior to coupling thefemale and male connectors 100, 200, the contamination containmentsurface 182b is exposed to the ambient. Preferably, the membraneassembly 170b comprises a homogeneous membrane sheet. Thus, both coverlayers 178b, 181b also preclude the passage of bacteria therethrough.Accordingly, while the cover layers 178b, 181b are protectively disposedover the sealing layer 172b, they isolate the sealing layer from theambient contaminants and from surfaces exposed to the ambient.

In the embodiment of FIG. 5b, the membrane assembly 270b of the maleconnector 200 can be constructed in a fashion analogous to the membraneassembly 170b of the female connector 100. Reference numerals forcomponents of the membrane assembly 270b are analogous to the numeralsfor the membrane assembly 170b, except that the 200 series is used.

In use, the hollow stem 210 forms an isolated portion of the fluidcommunication path. On the proximate side of the internal chamber 231 ofthe male connector 200, the membrane assembly 270 preferably seals thehollow stem 210 therein. On the distal side of the chamber 231, thetelescoping seal assembly 225 preferably seals the stem 210 therein. Asexemplified in FIG. 7, in final assembly the stem 210 is adapted tobridge the chambers 141, 231. Accordingly, the stem 210 is free to moveaxially within the bore 234, toward the proximate end of the malefitting 230.

To establish fluid communication between the internal chambers 141, 231,the connectors 100, 200 are first positively interlocked. The connectors100, 200 may be interlocked by the tongue-in-groove coupling describedabove, for example. The resilient mount 249 is then compressed and urgesthe cover layers of the membrane assemblies 170, 270 into positivecontact against each other. The cover layers 178, 278 can then beremoved by pulling the tabs 179, 279. The biased opposition provided bythe resilient mount 249 simultaneously urges the protected sealinglayers of the membrane assemblies 170, 270 into positive contact againsteach other.

The stem 210 then can be advanced within the male fitting 230, typicallyby hand or by use of a tool. The stem 210 may advance within the sleeves232, 238 until the rim 233 formed on the distal end of the inside sleeve232 abuts the shoulder 224 formed on the stem 210. The mating taperedsurfaces of the rim 233 and the shoulder 224 provide yet another sealisolating from the ambient the internal chamber 231 as well as the stemportion or head 220 therein. This abutment also serves as a stop,ultimately limiting the axial travel of the stem 210. The advance of thestem 210 is sufficient to allow the stem 210 to pierce at least thesealing layer 172, 272 of each membrane assembly 170, 270, respectively.The head 220, which comprises a piercing element, may thus have apointed form for example, adapted for this penetration. By inserting thestem 210 into the female fitting 130, fluid communication is establishedbetween the female and male connectors 100, 200. Thus, the tubes 10, 20are joined in fluid communication, and a single fluid path is formedthrough the connector assembly.

Preferably, once the stem 210 is inserted into the female fitting 130,an axial restraint resists retraction of the stem 210. Such a restraintpreferably prevents altogether the retraction of the stem 210. Thisrestraint is implemented in the illustrated embodiment by a ratchet orlocking structure. The inside sleeve 232, including the tapered form ofthe rim 233 cooperates with the angle of the beveled ribs 216 to allowaxial advance of stem 210 toward the female connector 100 withsufficient resistance to prevent accidental or incidental movement ofthe stem 210. The distal end of the inside sleeve 232 may further beformed with a lip or catch 236 depending radially inward within the bore234. Upon attempting retraction of the stem 216, the beveled ribs 216may engage the catch 236. This engagement prevents axial retraction ofthe stem 210, locking the stem within the female fitting 130. Theratchet structure may additionally include engagement of the beveledribs 216 by an internal shoulder 235 (shown in FIG. 4) formed in thebore 234 of the sleeve 232, for example.

The axial restraint may also be implemented or augmented by thefrictional telescoping engagement of mating parts. This includes thetelescoping engagement of the plunger 226 and/or O-ring 227 within thebore 239. Also, both the head 220 of the stem 210 and the bore 142defined within the female fitting 130 may comprise mating tapered forms.Accordingly, the head 220 may be lodged in frictional telescopingengagement within the internal chamber 141 of the female connector 100,sealing the stem 210 within the female connector 100 and resistingdisengagement.

In another representative embodiment shown in FIGS. 8 and 9, componentscorresponding to the previous embodiment are denoted with the samereference numerals. The illustrated seal assembly 225 may furtherinclude a frangible flange 228, in addition to the plunger 226. Theoutside sleeve 238 may have a seat assembly 240 formed at the distal endthereof. The frangible flange 228 may be fixed to the seat assembly 240by any appropriate means, e.g. by bonding or welding, and may thus sealthe interior bore 239 defined within the outside sleeve 238. The seatassembly 240 may include a rim 242 which abuts the frangible flange 228when the latter is fixed to the seat assembly. Preferably, the frangibleflange 228 comprises an element which may be severed or broken. Moreparticularly, the frangible flange 228 may comprise a thin wall forexample. Further, the frangible flange 228 may have a cleavage or creaseformed on either side of the flange. The position of this crease wouldcoincide with the area where the rim 242 abuts the frangible flange 228.Also, the rim 242 may advantageously form a sharp edge.

The assembly of connectors 100, 200 of the embodiment of FIGS. 8 and 9may operate similarly to the earlier embodiment. After the connectors100, 200 are coupled and the removable cover layers are removed from themembrane assemblies 170, 270, the stem 210 can be advanced. The stem 210may be forcibly advanced by hand or tool such that the flange 228 issevered or broken against the rim 242. As the stem 210 is advanced, theplunger 226 moves along the wall of the bore 239. The plunger 226 mayagain be advantageously formed from a compressible material, for examplean elastomeric material. Contact between the plunger 226 and the wall ofthe bore 239 provides a secure seal from the ambient for both bores 239,234 and the internal chamber 231. Also, part of the frangible flange 228remaining with the plunger 226 preferably comprises a material which mayyield, compressing radially or folding at its periphery, for example.Thus, the remaining portion of the severed flange 228 may initiallyenter and advance within the bore 239 while constantly maintainingsealed contact with the tapering wall defining the bore 239.

In summary, in this embodiment of the connector assembly, at least fourmechanisms advantageously cooperate to isolate from the ambient thedistal end of the internal chamber 231. Originally, prior to advancingthe stem 210, the frangible flange 228 may be fixed to the seat assembly240, sealing the bore 239. Once the stem 210 is advanced, the peripheryof the remaining portion of the frangible flange 228 intimately contactsthe wall defining the bore 239. Similarly, the plunger 226 alsointimately contacts the tapering wall of the bore 239. Finally, theabutting tapered surfaces of the rim 233 of the inside sleeve 232 andshoulder 224 of the stem 210 mate to seal the bore 234.

In an alternate embodiment, illustrated in FIGS. 11-12, the connectorassembly comprises a female connector 100 and a male connector 200 asdescribed above for FIGS. 1-4. In this embodiment of the invention, maleconnector 200 includes a stem 310 preferably housed within a sealedchamber or aperture 231 defined within a fitting 230. Male connector 200includes an inside sleeve 232, the distal end of which may be formedwith at least one lip or catch 236, as noted above. In the illustratedembodiment, the sleeve 232 has three catches 236 equally spaced from oneanother.

The stem 310 may also be formed with a first ratchet structure 311 and asecond ratchet structure 312. For example, each ratchet structure 311and 312 may include beveled annular ribs formed on the external surfaceof the stem 310. These ribs are shown in plain, non-sectioned elevationin the partially cross sectioned FIGS. 11 and 12. The ribs maycircumfuse the external surface of the stem 310. The ribs may be beveledsuch that they project from the surface of the stem 310, extendingdistally toward the base 223 of the stem 310 and forming an acute anglewith the external surface of the stem 310. Tapers can be formed at theproximate end of the catches to guide the contact of the catches withthe first and second ratchet structures.

In a preferred embodiment, stem 310 also includes a relatively smoothexternal surface 313 between first ratchet structure 311 and secondratchet structure 312, i.e., a surface which minimizes resistance to themovement of the stem 310 into the female connector 100 until fullyengaged.

In use, the hollow stem 310 forms an isolated portion of the fluidcommunication path, as described above. The inside sleeve 232, includingthe tapered form of the rim 233 cooperates with the angled surface ofthe beveled ribs to allow axial advance of stem 310 toward the femaleconnector 100 with sufficient resistance to prevent accidental orincidental movement of the stem 310. The stem 310 can be advanced withinthe male fitting (CONNECTOR) 200 by applying sufficient force toovercome the engagement of the catch 236 with the beveled rib(s) offirst ratchet structure 311. In a preferred embodiment of the invention,the force required to move the rib(s) of the first ratchet structure 311past the catch 236 is greater than the force required to move the rib(s)of the second ratchet structure 312 past the catch 236. For example, thebevel on the rib(s) of the first ratchet structure may be greater thanthe bevel on the rib(s) of the second ratchet structure.

Once the stem 310 is inserted into the female fitting 130, an axialrestraint resists retraction of the stem 310. Such a restraintpreferably prevents altogether the retraction of the stem 310. Thisrestraint is implemented in the illustrated embodiment by the secondratchet structure 312 which engages with catch 236. Upon attemptingretraction of the stem 310, the engagement of the beveled ribs with thecatch 236 prevents axial retraction of the stem :310, locking the stemwithin the female fitting 130.

As with all illustrated embodiments herein, a number of variations inthe illustrated constructions are envisioned. For example, anotherembodiment for the female connector 100 is illustrated in FIG. 10, whereanalogous components have the same reference numerals. In thisembodiment, the counter bore 144 is closed at a blind end by apierceable septum 147 and the septum 147 may comprise an integral partof the flange 150. Thus, the chamber 141 defined within the tubing 10 issealed by both the membrane assembly 170 and the septum 147. The septum147 may provide additional security in sealing the chamber 142 fromambient contaminants and from surfaces previously exposed to theambient. The septum 147 may also resist the pressure of the fluid in thetubing section better than the membrane assembly 170. When the femaleand male connectors 100, 200 are coupled, the stem 210 can be axiallyadvanced through the sleeve 232 to pierce three elements: the membraneassembly 270 of the male connector 200 and the membrane assembly 170 andthe septum 147 of the female connector. In one possible mechanism foraxial restraint of the stem, a throat may be formed where the septum ispierced, whereby the stem registers in an intimate friction fit withinthe throat.

Other variations are also envisioned. For example, where the femaleconnector and fluid conduit comprise separate components, they could beconnected by a variety of other means, e.g. mating threaded fittings.Alternatively, the bracket may be attached to a sleeve, either formedintegrally with the bracket or otherwise connected thereto. This sleevemay be connected to a section of tubing through telescopic engagement,i.e. a coaxial friction fit wherein one member is inserted within theother, with friction between the two members retaining the coupling. Inanother variant construction for the female connector, the two bores andthe tubing can be variously configured. In the exemplary embodiment ofFIGS. 1-3 these components are generally cylindrical. Alternatively,they may be formed with cross sections of various geometries, forexample rectangular or elliptical.

A number of variations are envisioned in the,construction of the maleconnector. The hub and/or sleeve may assume cross sections of anysuitable form, for example rhomboid or trapezoidal. Also, the sleeve,flange and/or hub, for example, can be molded or machined as separateparts, each with mating threads. The sleeve can also be constructed asseparate, hollow telescoping sections housing a helical spring, forexample. This may serve as a substitute for the illustrated constructionof the resilient mount. The telescoping sections of the sleeve can bedimensioned to allow easy axial reciprocation of one half within theother. The spring would provide the resilience necessary to couple theconnectors in biased opposition, maintaining positive contact betweenmembrane assemblies. If the spring is helical, it can be sized such thatthe stem can be loosely housed, allowing for axial displacement withinthe helix. In another alternative to the illustrated construction of theresilient mount, the male fitting can alternatively be formed ormachined as an integral piece from a post of elastomeric material. Thispost would be bored to make it a hollow sleeve, and may be constructedwithout a separate hub piece. Alternatively, a separate elastomeric hubcan be mounted on a sleeve piece.

The axial resilience in the coupling can alternatively be provided byusing a deformable or resilient material for one or both sealing layersof the membrane assemblies. The resilience and thickness in the sealinglayer should provide the compliance and clearance necessary to urge thecontamination containment surfaces into positive contact. Hence, thesealing layers may be made thick relative to the cover layers. Theremovable cover layers may be made thin relative to the sealing layersto make removal easy while assuring positive contact of interfacingintermediate surfaces.

The illustrated structure for coupling the female and male connectorscan also be modified. The exemplary tongue-in-groove coupling can bereplaced with any coupling, preferably an interlocking structure whichlocks or becomes non-separable after coupling. A rabbeted coupling, forexample, can be implemented by forming one connector with a groove orrecess cut out of an edge or face of its body. The other connector canbe formed with a boss or rib having a shape that mates with that recess.In another alternative coupling, the female and male connectors cancomprise any suitable form of mating threaded fittings.

Several alternative constructions for the axial restraint of the stemare possible. An axial restraint can be implemented by severalembodiments of a friction fit, for example. The counter bore within thefemale fitting may be proportioned to accommodate any flaps formed whenthe membrane assemblies are pierced. As the stem passes, the flaps canbe pressed radially against the inside wall of the counter bore. A tightfriction fit may be formed with the flaps of the pierced membrane caughtbetween the stem and the wall of the counter bore. Withdrawal of thestem from the female fitting may be prevented in part by friction.Forward edges of the membrane flaps may also engage the annular beveledribs, preventing withdrawal of the stem.

In another alternative for the axial restraint, the stem and the malefitting may be formed as telescoping parts, coaxially engaging in afriction fit. These components may have tapered or conic sections, forexample. Additionally or alternatively, these components may be formedwith a rabbeted structure, e.g., a rib or lug may be formed on onecomponent to engage in a mating recess formed in the other.

In the illustrated assembly of female and male connectors it may bedesirable to ensure that accidental or incidental insertion of the stemthrough the membrane assemblies is prevented. Accordingly, the connectorassembly can additionally be equipped with a mechanism initiallypreventing insertion of the stem. In one embodiment, this mechanism maybe implemented by forming the proximate end of the stem with arelatively dull nipple rather than a head with a sharp tip.Additionally, the sealing and cover layers within a given membraneassembly could comprise different materials, e.g., materials whichstrongly resist being pierced by the stem. The nipple may also have aform which can penetrate one of the sealing or cover layers, but not theother. In another embodiment, this mechanism may comprise a camstructure. The connector housing the stem, e.g. the male fitting 230 inthe illustrated embodiments, may have a slot formed in the sleeve andthe stem may be formed with a lug which serves as a cam. The cam canprevent axial advance of the stem when it abuts the rim of the sleeve,but upon twisting the stem to align the cam with the slot in the sleevethe stem 210 is freed from the locking action of the cam. The stem maythen be inserted into the female connector, piercing the membraneassemblies.

The connector assembly may be utilized in conjunction with various fluiddelivery systems such as intravenous (IV) devices, which includeflexible and/or rigid fluid containers. The connector assembly--fluiddelivery system combination may be utilized to supply, for example,parenteral and biological fluids. As used herein, a parenteral fluid isa physiologically acceptable fluid, which is preferably sterile.Examples of parenteral fluids include saline solution, i.e., isotonic(about 0.9%) sterile saline solution, and an electrolyte solution,including for example, dextrose 5% in water (D5W). Biological fluids, asused herein, are fluids originating from a living organism, for example,blood and blood components.

An exemplary embodiment of a connector assembly--fluid delivery systemcombination is illustrated in FIG. 14, where analogous components havethe same reference numbers as the connector assembly of FIG. 1. In FIG.14, the female connector 100 of the connector assembly is connected to acontainer 600 via tubing 10. The tubing 10, as described previously, maybe connected to the female connector 100 in any suitable manner, e.g.,by utilizing solvents, bonding agents, hose clamps, ultrasonic welding,threaded connectors, or friction fitting. Alternatively, the tubing 10may be molded to the female connector 100 as an integral part thereof.The tubing 10 may be connected to the flexible container 600 through afitment which allows fluid communication between the tubing 10 and thecontainer 600. The fitment may include a valve such as a transfer legclosure which controls fluid flow to or from the container 600. Thefemale connector 100, the tube 10, and the container 600 may beconstructed as a single, integral unit.

The tubing 20 connected to the male connector 200 of the connectorassembly may be connected to other components comprising the fluiddelivery system (not illustrated). For example, the tubing 20 may beconnected to a series of connector assembly--fluid delivery systemcombinations, to a syringe, or to a filtration system. In addition,although not illustrated the male connector 200 of the connectorassembly may be connected to the container 600, i.e., the roles of themale and female connectors 200, 100 may be reversed. In such anembodiment, the male connector 200, the tube 20, and the container 300may be constructed as a single, integral unit.

The container 600 as well as the tubing 10, 20 which may be utilized inaccordance with the connector assembly of the present invention may beconstructed of any material compatible with parenteral and biologicalfluids. The composition of the container 600 and the tubing 10, 20 mayvary with the nature of the particular fluid utilized. A wide variety ofsuitable containers and tubes are already known in the art. Exemplarycontainers include, but are not limited to syringes, flexible bags, andrigid containers. The container 600 may be formed from various materialssuch as metallic materials, glass, and plastics, including polyvinylchloride (PVC). The container 300 preferably comprises plasticized PVCfor flexibility and strength. Typical tubes comprise flexible plastics,such as plasticized PVC, for ease of use. It is intended that theinvention should not be limited by the type or composition of thecontainer and/or tubing being employed.

The connector assembly illustrated in FIG. 14 is similar to theconnector assembly illustrated in FIG. 1. Specifically, the maleconnector 200 comprises the stem 210 having a head 220 which may includea piercing member 220a, the fitting 230, and the resilient mount 249.The female connector 100 comprises the fitting 130 including a bore 142for receiving the piercing member. The connector assembly illustrated inFIG. 14, however, preferably comprises modified female and male membraneassemblies 400 and 500 as opposed to the membrane assemblies 170, 270illustrated in FIGS. 5a and 5b. In the membrane assemblies 170, 270previously described, each membrane assembly may include at least twolayers, the first layer defining a removable contamination containmentsurface and the second layer defining a sealing surface. In theexemplary embodiment of FIG. 14, only the female and male contaminationcontainment layers 400 and 500 are sealed to the connectors 100, 200.Preferably, the female and male contamination containment layers 400 and500 have the double fold configuration and each comprise pull tabs 402,502, intermediate surfaces 404, 504, contamination containment surfaces406, 506, and cover layers 408, 508.

The female and male contamination containment layers 400 and 500 maycomprise impermeable materials, such as glassine paper or impermeablepolymeric films, or permeable materials, including papers such as Tyvek™paper or porous polymeric films, which preclude the passage of bacterialcontaminants. Permeable or porous materials offer the advantage, ifdesired, of allowing sterilizing gases, including ethylene oxide gas, topenetrate therethrough and spread to the interior of the female and maleconnectors 100, 200, thereby sterilizing them without having to removethe female and male contamination containment layers 400 and 500. Eitherpermeable or impermeable materials are suitable for gamma or steamsterilization. Additionally, a bacteriostatic or bacteriocidal compoundor layer (not illustrated) may be disposed on either or bothcontamination containment surfaces 406, 506.

The female and male contamination containment layers 400 and 500function in a similar manner as the membrane assemblies 170 and 270illustrated in detail in FIGS. 5a and 5b. Basically, once the femaleconnector 100 and the male connector 200 are connected as previouslydescribed, the female and male contamination containment layers 400 and500 are removed by pulling the tabs 402, 502 and the stem 210 isinserted into the bore 142. Because the female and male contaminationcontainment layers 400 and 500 are removed, no piercing member isnecessary on the head 220 of the stem 210, as illustrated in FIG. 1, topuncture the sealing surfaces 172a and 272a. However, the head 220 ofthe stem 210 preferably comprises a shape which frictionally engages thewalls of the bore 142 in the female connector 100. Alternatively, themembrane assemblies 170 and 270 described in detail with respect toFIGS. 5a and 5b may be utilized in the embodiment of FIG. 14. In thiscase, a piercing member 220a would again be preferable. In addition, ifsealing layers are utilized, the gas can penetrate the porous materialand sterilize the sealing surfaces without having to remove thecontamination containment surfaces.

An exemplary alternate embodiment of a connector assembly--fluiddelivery system combination is illustrated in FIG. 15, where analogouscomponents have the same reference numbers as the components in FIG. 14.Once again, the male connector 200 comprises the stem 210 having a head220, the fitting 230, the resilient mount 249, and the malecontamination containment layer 500. The female connector 100 comprisesthe fitting 130, including a bore 142, and the female contaminationcontainment layer 400. In this embodiment, however, the female connector100 may be connected directly to the container 600. For example, asillustrated, the female connector 100 may be fitted with a transfer legclosure 602. In contrast to the female connector 100 illustrated in FIG.1, wherein the tube 10 is connected to the fitting 130, the fitting 130may be mounted directly to the fitment 602 of the container 600.Preferably, the female connector 100 and the container 600 may beconstructed as a single integral unit.

As described above, the tubing connected to the male connector 200 ofthe connector assembly may be connected to other components in the fluiddelivery system. For example, the tubing 20 may be connected to a seriesof connector assembly-fluid delivery system combinations, to a syringe,or to a filtration system. In addition, although not illustrated, themale connector 200 of the connector assembly may be connected to thecontainer 300.

In the embodiment illustrated in FIG. 15, the female and malecontamination containment layers 400 and 500 are utilized in a similarmanner as described with reference to FIG. 14. Basically, once thefemale connector 100 and the male connector 200 are connected aspreviously described, the female and male contamination containmentlayers 400 and 500 are removed by pulling the tabs 402, 502 and the stem210 is inserted into the bore 142. Because the female and malecontamination containment layers 400 and 500 are removed, piercingmember is necessary on the head 220 of the stem 210, as illustrated inFIG. 1, to puncture the sealing surfaces 172a and 272a. Alternatively,the membrane assemblies 170 and 270 described in detail with respect toFIGS. 5a and 5b may be utilized in the embodiment of FIG. 15. In thiscase, a piercing member would again be necessary.

Once the female and male connectors 100, 200 are interlocked, the femaleand male contamination containment layers 400, 500 removed, or thecontamination containment surfaces of the membrane assemblies 170, 270removed and the sealing surfaces punctured by the piercing member, thetransfer leg closure is opened to initiate the fluid flow.

FIG. 16 illustrates an exemplary embodiment of a connectorassembly--fluid delivery system combination wherein a modified femaleconnector 100 of the connector assembly is mounted directly to the wallof a container 300. Once again, analogous components have the samereference numbers as used in FIGS. 14 and 15. In this embodiment, thefemale connector 100 is different from the previously described femaleconnectors 100. Essentially, in this embodiment, only the bracket 148 ofthe female connector 100 is utilized. As in the previously describedembodiments, the U-shaped bracket is defined by a flange 150 and one ormore tongues 158. The flange 150 may have a generally disc-shapedconfiguration with an aperture 148a in the center. The tongues 158extend away from the flange 150 in a direction away from the container600. The tongues 158 can thus register in grooves 248 (illustrated inFIG. 3), formed in the flange 246 of the male connector 200.Accordingly, tongues 158 can be adapted to couple the female and maleconnectors 100, 200 in a tongue-in-groove engagement as in thepreviously described and illustrated embodiments. Alternativearrangements for the connection of the female and male connectors 100,200 are also possible,and may include, for example, threaded connectors.In an alternate embodiment, the fitting 130 of the female connector 100may extend into the container 300. The male connector 200 as withpreviously described embodiments comprises the same basic components,i.e., the stem 210 with a head 220, the fitting 230, the resilient mount249 and the male contamination containment layer 500.

The female connector 100 may be connected to the wall of the container600 by a variety of means. In the exemplary embodiment illustrated inFIG. 16, the female connector 100 is connected to a major surface of thecontainer 600. The area of the wall where the female connector 100 isconnected may be reinforced so that the female connector 100 will nottear away a portion of the wall. The reinforcement may be in the form ofEl grommet or any other suitable reinforcement means. The femaleconnector 100 may be bonded or welded to the container 600 or may beformed integrally therewith.

In the embodiment illustrated in FIG. 16, the female and malecontamination containment layers 400 and 500 are utilized in the samemanner as described with reference to FIG. 14. Alternatively, oradditionally, the membrane assemblies 170 and 270 described in detailwith respect to FIGS. 5a and 5b may be utilized in place of the femaleand male contamination containment layers 400 and 500. Basically, oncethe female connector 100 and the male connector 200 are interlocked aspreviously described, i.e., for example, via the tongue-in-groovearrangement, the female and male contamination containment layers 400and 500 are removed by pulling the tabs 402, 502. The stem 210 is thenmoved from the male connector 200, through the aperture 148a in thefemale connector 100, and through the wall of the container 600, thepiercing member piercing the wall of the container 600, thereby forminga fluid path therethrough. The aperture 148a may be sized to sealagainst the head 220 of the stem 210 which is preferably tapered toprovide an increasingly snug fit and seal at the walls of the bracket148 defining the aperture 148a. Alternatively, the female connector 100may comprise a sealing member such as an 0-ring to provide a fluid tightseal between the head 220 and the aperture 148a.

Although shown and described is what are believed to be the mostpractical and preferred embodiments, it is apparent that departures fromspecific methods and designs described and shown will suggest themselvesto those skilled in the art and may be used without departing from thespirit and scope of the invention. The present invention is notrestricted to the particular constructions described and illustrated,but should be constructed to cohere with all modifications that may fallwithin the scope of the appended claims.

I claim:
 1. A connector assembly comprising:a first fitting defining afirst aperture; a second fitting couplable to the first fitting anddefining a second aperture; a stem member mounted in the first fittingand including a head axially movable into the aperture of the secondfitting; and a ratchet mechanism mounted to the stem to lock the headwithin the second aperture of the second fitting, the ratchet mechanismincluding first and second ratchet structures spaced apart from oneanother and a section between the first and second ratchet structureshaving a lower resistance to movement of the stem member than the firstand second ratchet structures.
 2. The connector assembly according toclaim 1, wherein the first and second ratchet structures each compriseat least one rib formed on an external surface of the stem.
 3. Theconnector assembly according to claim 2, wherein the at least one rib ofeach of the first and second ratchet structures is beveled and projectsfrom the external surface of the stem extending in a direction away fromthe second fitting and forming an acute angle with the external surfaceof the stem.
 4. The connector assembly according to claim 3, wherein thesecond ratchet structure comprises a plurality of beveled ribs.
 5. Theconnector assembly according to claim 4, wherein the at least onebeveled rib of the first ratchet structure has a greater bevel than theplurality of beveled ribs of the second ratchet structure.
 6. Theconnector assembly according to claim 1, wherein the section between thefirst and second ratchet structures comprises a substantially smoothexternal surface of the stem.
 7. The connector assembly according toclaim 1, wherein the first fitting further comprises a sleeve includinga catch engageable with at least one of the beveled ribs of the firstand second ratchet structures to prevent retraction of the head from theaperture of the second fitting.
 8. The connector assembly according toclaim 7, wherein the sleeve includes three catches equally spaced fromone another.
 9. The connector assembly according to claim 7, wherein thecatch extends radially inward from the inner periphery of the sleeve.10. A method for making a contaminant-free connection comprising:matinga first fitting and a second fitting; establishing a fluid flowpaththrough the first and second fittings by advancing a stem having a headfrom the first fitting into the second fitting, including moving thestem against a first resistance, a second resistance substantially lessthan the first resistance, and a third resistance substantially greaterthan the second resistance; and locking the head of the stem in theaperture of the second fitting.
 11. The method for making acontaminant-free connection according to claim 10, wherein moving thestem against a first resistance includes applying a first force toovercome an engagement of a catch and a beveled rib of a first ratchetassembly of a ratchet mechanism, and wherein locking the head of thestem in the aperture of the second fitting includes locking the head ofthe stem in the aperture of the second fitting by means of the ratchetmechanism.
 12. The method for making a contaminant-free connectionaccording to claim 11, wherein moving the stem against a secondresistance includes applying a second force to slide the stem between afirst ratchet structure and a second ratchet structure of the ratchetmechanism.
 13. The method for making a contaminant-free connectionaccording to claim 12, wherein moving the stem against a thirdresistance includes applying a third force to overcome an engagement ofa catch and at least one beveled rib of a second ratchet assembly of theratchet mechanism.
 14. The method for making a contaminant-freeconnection according to claim 13, wherein applying a second forceincludes sliding the stem along a smooth walled stem between the firstand second ratchet structures.
 15. A fluid delivery systemcomprising:(a) a connector assembly including a first fitting defining afirst aperture, the first fitting including a first removablecontamination containment layer sealing the first aperture, a secondfitting defining a second aperture, the second fitting including asecond removable contamination containment layer sealing the secondaperture, and a resilient member positioned between the first and secondfittings and communicating with the first and second apertures, theresilient member including a hub and a neck joined to the hub; (b) acontainer for holding fluids; and (c) tubing which couples the containerto one of the first and second fittings.
 16. A fluid delivery systemcomprising:(a) a connector assembly including a first fitting defining afirst aperture, the first fitting including a first removablecontamination containment layer sealing the first aperture, a secondfitting couplable to the first fitting and defining a second aperture,the second fitting including a second removable contaminationcontainment layer sealing the second aperture, and a stem member mountedin the first fitting and including a head axially movable into theaperture of the second fitting; (b) a container for holding fluids; and(c) tubing which couples the container to one of the first and secondfittings.
 17. The fluid delivery system according to claim 16, furthercomprises a ratchet mechanism mounted to the stem to lock the headwithin the second aperture of the second fitting.
 18. The fluid deliverysystem according to claim 17, wherein the ratchet mechanism includesfirst and second ratchet structures spaced apart from one another and asection between the first and second ratchet structures having a lowerresistance to movement of the stem than the first and second ratchetstructures.
 19. The fluid delivery system according to claim 18, whereinthe first and second ratchet structures each comprise at least one ribformed on an external surface of the stem.
 20. The fluid delivery systemaccording to claim 19, wherein the section between the first and secondratchet structures comprises a substantially smooth external surface ofthe stem.
 21. The fluid delivery system according to claim 20, whereinthe substantially smooth external surface of the stem member minimizesresistance to the axial movement of the stem into the second aperture ofthe second fitting.
 22. The fluid delivery system according to claim 21,wherein the first fitting further comprises a sleeve including a catchengageable with at least one of the beveled ribs of the first and secondratchet structures.
 23. The fluid delivery system according to claim 22,wherein the sleeve includes three catches equally spaced from oneanother.
 24. The fluid delivery system according to claim 23, whereinthe catch extends radially inward from the inner periphery of thesleeve.
 25. The fluid delivery system according to claim 24, wherein theconnector assembly further comprises a resilient mount positionedbetween the first and second fittings and communicating with the firstand second apertures.
 26. The fluid delivery system according to claim25, wherein the resilient mount includes a hub and a neck joined to thehub.
 27. The fluid delivery system according to claim 26, wherein the atleast one rib of each of the first and second ratchet structures isbeveled and projects from the external surface of the stem extending ina direction away from the second fitting and forming an acute angle withthe external surface of the stem.
 28. The fluid delivery systemaccording to claim 27, wherein the second ratchet structure comprises aplurality of beveled ribs.
 29. The fluid delivery system according toclaim 28, wherein the at least one beveled rib of the first ratchetstructure has a greater bevel than each of the plurality of beveled ribsof the second ratchet structure.
 30. The fluid delivery system of claim29, wherein the at least one beveled rib of the first ratchet structureand the plurality of beveled ribs of the second ratchet structurecircumfuse the stem.
 31. A fluid delivery system comprising:(a) aconnector assembly including a first fitting defining a first aperture,a second fitting couplable to the first fitting and defining a secondaperture, and a stem member mounted in the first fitting and including ahead axially movable into the aperture of the second fitting; (b) acontainer for holding fluids; and (c) tubing coupling the container toone of the first and second fittings, the tubing being connecteddirectly to the container and to one of the first and second fittings.32. The fluid delivery system according to claim 31, wherein thecontainer comprises a fitment which is connected directly to the tubing.33. The fluid delivery system according to claim 32, wherein the fitmentcomprises a transfer leg closure.
 34. The fluid delivery systemaccording to claim 33, wherein the tubing is connected directly to oneof the first and second fittings.
 35. The fluid delivery systemaccording to claim 33, wherein the tubing comprises a material suitablefor parenteral and biological fluids.
 36. The fluid delivery systemaccording to claim 35, wherein the tubing comprises plasticized PVC. 37.The fluid delivery system according to claim 31, wherein the containeris connected directly to one of the first and second fittings.
 38. Thefluid delivery system according to claim 31, wherein the containercomprises a flexible bag.
 39. The fluid delivery system according toclaim 31, wherein the container comprises a rigid container.
 40. Thefluid delivery system according to claim 31, wherein the containercomprises a syringe.
 41. The fluid delivery system according to claim31, wherein the container comprises a material suitable for parenteraland biological fluids.
 42. The fluid delivery system according to claim41, wherein the container comprises plasticized PVC.
 43. The fluiddelivery system according to claim 15, wherein the connector assemblyfurther comprises a stem member including a head mounted in the firstfitting and axially movable into the aperture of the second fitting. 44.The fluid delivery system according to claim 43, wherein the connectorassembly further comprises a ratchet mechanism mounted to the stem tolock the head within the second aperture of the second fitting.
 45. Thefluid delivery system according to claim 44, wherein the ratchetmechanism includes first and second ratchet structures spaced apart fromone another and a section between the first and second ratchetstructures having a lower resistance to movement of the stem than thefirst and second ratchet structures.
 46. The fluid delivery systemaccording to claim 45, wherein the first and second ratchet structureseach comprise at least one rib formed on an external surface of thestem.
 47. The fluid delivery system according to claim 46, wherein theat least one rib of each of the first and second ratchet structures isbeveled and projects from the external surface of the stem extending ina direction away from the second fitting and forming an acute angle withthe external surface of the stem.
 48. The fluid delivery systemaccording to claim 47, wherein the second ratchet structure comprises aplurality of beveled ribs.
 49. The fluid delivery system according toclaim 48, wherein the at least one beveled rib of the first ratchetstructure has a greater bevel than each of the plurality of beveled ribsof the second ratchet structure.
 50. The fluid delivery system of claim49, wherein the at least one beveled rib of the first ratchet structureand the plurality of beveled ribs of the second ratchet structurecircumfuse the stem.
 51. The fluid delivery system according to claim45, wherein the section between the first and second ratchet structurescomprises a substantially smooth external surface of the stem.
 52. Thefluid delivery system according to claim 15, wherein the hub defines arim and wherein the first removable contamination containment layercontacts the rim.
 53. The fluid delivery system according to claim 15,wherein the hub has a first diameter and the neck has a second diameterless than the first diameter.
 54. The fluid delivery system according toclaim 15, wherein the container, the tubing, and one of the first andsecond fittings comprise a single integral unit.
 55. The fluid deliverysystem according to claim 15, wherein the tubing and one of the firstand second fittings comprise a single integral unit.
 56. The fluiddelivery system according to claim 15, wherein the tubing comprises amaterial suitable for parenteral and biological fluids.
 57. The fluiddelivery system according to claim 56, wherein the tubing comprisesplasticized PVC.
 58. The fluid delivery system according to claim 15,wherein the container comprises a flexible bag.
 59. The fluid deliverysystem according to claim 15, wherein the container comprises a rigidcontainer.
 60. The fluid delivery system according to claim 15, whereinthe container comprises a syringe.
 61. The fluid delivery systemaccording to claim 15, wherein the container comprises a materialsuitable for parenteral and biological fluids.
 62. The fluid deliverysystem according to claim 61, wherein the container comprisesplasticized PVC.
 63. The connector assembly according to claim 5,wherein the at least one beveled rib of the first ratchet structurecircumfuses the stem.
 64. The connector assembly according to claim 5,wherein the plurality of beveled ribs of the second ratchet structurecircumfuses the stem.
 65. The connector assembly according to claim 1,wherein the first and second ratchet structures each comprise at leastone latch formed on an external surface of the stem.
 66. The connectorassembly according to claim 65, wherein the at least one latch of eachof the first and second ratchet structures comprises a rib which isbeveled and projects from the external surface of the stem extending ina direction away from the second fitting and forming an acute angle withthe external surface of the stem.
 67. The connector assembly accordingto claim 66, wherein the second ratchet structure comprises a pluralityof beveled ribs.
 68. The connector assembly according to claim 67,wherein the at least one beveled rib of the first ratchet structure hasa greater bevel than the plurality of beveled ribs of the second ratchetstructure.
 69. The connector assembly according to claim 68, wherein theat least one beveled rib of the first ratchet structure and theplurality of beveled ribs of the second ratchet structure circumfuse thestem.
 70. The connector assembly according to claim 68, wherein thesection between the first and second ratchet structures comprises asubstantially smooth external surface of the stem.
 71. The connectorassembly according to claim 69, wherein the first fitting furthercomprises a sleeve including a catch engageable with at least one of thebeveled ribs of the first and second ratchet structures to preventretraction of the head from the aperture of the second fitting.
 72. Theconnector assembly according to claim 71, wherein the sleeve includesthree catches equally spaced from one another.
 73. The connectorassembly according to claim 71, wherein the catch extends radiallyinward from the inner periphery of the sleeve.
 74. The connectorassembly according to claim 9, wherein the catch of the sleevecooperates with at least one of the beveled ribs of the first and secondratchet structures to allow axial advance of the stem member into thesecond fitting with sufficient resistance to prevent accidental movementof the stem member and to prevent axial retraction of the stem member.75. The connector assembly according to claim 53, wherein the catch ofthe sleeve cooperates with at least one of the beveled ribs of the firstand second ratchet structures to allow axial advance of the stem memberinto the second fitting with sufficient resistance to prevent accidentalmovement of the stem member and to prevent axial retraction of the stemmember.
 76. The connector assembly according to claim 6, wherein thesubstantially smooth external surface of the stem member minimizesresistance to the axial movement of the stem into the second aperture ofthe second fitting.
 77. The connector assembly according to claim 5,wherein the section between the first and second ratchet structurescomprises a substantially smooth external surface of the stem.
 78. Theconnector assembly according to claim 70, wherein the substantiallysmooth external surface of the stem member minimizes resistance to theaxial movement of the stem into the second aperture of the secondfitting.
 79. The connector assembly according to claim 77, wherein thesubstantially smooth external surface of the stem member minimizesresistance to the axial movement of the stem into the second aperture ofthe second fitting.
 80. The method of claim 10, further compriseslodging in frictional telescoping engagement an exterior portion of thestem with an interior portion of a wall defining a bore of an internalchamber of the second fitting to establish a fluid flow path through thefirst and second fittings.
 81. The method of claim 80, further comprisesbreaking a component prior to or during lodging the stem within aninterior portion of a wall defining the bore.